PROGENIX™ DBM Putty is intended for use as a bone graft substitute, and bone void filler in bony voids or gaps of the pelvis, ilium and extremities not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PROGENIX™ DBM Putty provides a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process.

Device Description

PROGENIX™ DBM Putty contains human demineralized bone matrix (DBM) in a biocompatible carrier. The carrier is a mixture of bovine collagen with a natural polysaccharide (sodium alginate). The components are mixed in phosphate buffered saline to achieve a flowable or moldable consistency. All DBM used in the preparation of Progenix DBM Putty must induce bone formation when evaluated a validated athymic nude rat assay. Additionally, every lot of PROGENIX DBM PUTTY must also induce bone formation in this assay system prior to being released for use. Findings from an animal model are not necessarily predictive of human clinical results. PROGENIX™ DBM Putty is a single use product intended for use in filling bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. Additionally, this product is not designed to impart any mechanical strength to the surgical site. PROGENIX™M DBM Putty is provided in ready-to-use malleable forms that may be molded or manipulated by the surgeon into various shapes. This product has been shown to be osteoconductive as well as osteoinductive in an athymic rat assay, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing.

AI/ML Overview

This document is a 510(k) summary for a medical device (PROGENIX™ DBM Putty), which focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting detailed clinical study results with specific acceptance criteria and performance metrics. Therefore, much of the requested information regarding acceptance criteria, specific study designs, sample sizes, expert involvement, and comparative effectiveness is not typically found in such a submission.

However, based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Must induce bone formation when evaluated in a validated athymic nude rat assay (for all DBM used in preparation).	The document states: "All DBM used in the preparation of Progenix DBM Putty must induce bone formation when evaluated a validated athymic nude rat assay." (This implies it met the criterion).
Must induce bone formation in an athymic nude rat assay prior to being released for use (for every lot of PROGENIX DBM PUTTY).	The document states: "Additionally, every lot of PROGENIX DBM PUTTY must also induce bone formation in this assay system prior to being released for use." (Implies meeting this criterion is a prerequisite for release).
Osteoconductive and osteoinductive properties, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing.	"This product has been shown to be osteoconductive as well as osteoinductive in an athymic rat assay, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing."
Substantial equivalence to previously cleared bone void fillers.	The device was found substantially equivalent to predicate devices: DBX Demineralized Bone Matrix Putty and Paste (K040262), ALLOMATRIX® Putty (K041168), GRAFTON PLUS® DBM Paste (K040348), and OSTEOFIL® DBM Paste (K043420).
Viral inactivation for tissue and collagen components.	Processing steps for tissue and collagen were "validated to inactivate a panel of viruses representative of those which are clinically relevant."
Cortical bone processing demonstrated to inactivate viruses.	The cortical bone underwent a proprietary process "demonstrated to invalidate viruses."
Additional steps to inactivate viruses in DBM.	The DBM underwent "additional steps which are also effective in inactivating viruses."

2. Sample Sizes Used for the Test Set and Data Provenance

Sample Size: Not specified for the athymic nude rat assay. Clinical human trial data, or a 'test set' in the typical sense for medical imaging or AI, is not mentioned for performance evaluation. The substantial equivalence relies on comparison to predicate devices, not de novo clinical testing of this specific device's efficacy in humans.
Data Provenance: The athymic nude rat assay is an animal model. No country of origin is specified for the animal data. The study is prospective in the sense that each lot and all DBM used must undergo this testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. The primary performance evaluation cited is an animal model (athymic nude rat assay) and demonstration of substantial equivalence. There is no mention of a human 'test set' requiring expert adjudication for ground truth.

4. Adjudication Method for the Test Set

Not applicable as there is no human 'test set' requiring adjudication described in this document. The animal assay results would likely be evaluated by laboratory personnel or veterinarians, but no specific adjudication method is detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typical for diagnostic devices (e.g., AI in radiology) comparing human reader performance with and without AI assistance. This document describes a bone void filler device and its regulatory clearance based on substantial equivalence and animal model performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical product (DBM Putty), not an algorithm or AI system.

7. The Type of Ground Truth Used

For the performance claims (osteoconductivity, osteoinductivity, resorption), the ground truth is based on observations and measurements from the athymic nude rat assay. The assay itself is a validated model designed to assess bone formation.
For viral inactivation, the ground truth refers to the results of validated laboratory processing steps demonstrating viral inactivation.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a 'training set' in the context of an AI/machine learning model. The product's development and testing would involve R&D and quality control procedures, but not a "training set" like in AI development.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no 'training set' in the AI sense.

Summary

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Medtronic Sofamor Danek PROGENIX™ DBM Putty 510(K) Summary -K060794 December 2006

Medtronic Sofamor Danek USA, Inc. I. Company: 1800 Pyramid Place Memphis, TN 38132
DEC 1 8 2006
Edward S. Chin, D. Ph., MBA Contact: Group Director, Regulatory and Clinical Affairs (901) 396-3133
PROGENIX™ DBM Putty Proposed Proprietary Trade Name: II. Classification Name: Bone Void Filler Product Code: MOV 888.3045 Regulation No .:

III. Product Description/Purpose of Application

PROGENIX™ DBM Putty is a single use product intended for use in filling bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. Additionally, this product is not designed to impart any mechanical strength to the surgical site. PROGENIX™M DBM Putty is provided in ready-to-use malleable forms that may be molded or manipulated by the surgeon into various shapes. This product has been shown to be osteoconductive as well as osteoinductive in an athymic rat assay, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing.

The purpose of this application is to notify the FDA of our intent to market PROGENIX™ DBM Putty as a bone void filler.

IV. Indications

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V. Viral Inactivation

PROGENIX™ DBM Putty is produced from tissue and collagen which undergoes processing steps validated to inactivate a panel of viruses representative of those which are clinically relevant. The cortical bone used to produce the DBM undergoes a proprietary process demonstrated to inactivate viruses. Furthermore, the DBM undergoes additional steps which are also effective in inactivating viruses. These processing steps further reduce the risk of viral contamination beyond donor screening and testing.

V1 Substantial Equivalence

Documentation was provided which demonstrated PROGENIX™ DBM Putty to be substantially equivalent to previously cleared bone void fillers such as DBX Demineralized Bone Matrix Putty and Paste (Musculoskeletal Transplant Foundation, K040262, SE 03/17/05), ALLOMATRIX® Putty (Wright Medical Technology, K041168, SE 08/02/04), GRAFTON PLUS® DBM Paste (Osteotech, K040348, SE 11/23/05) and OSTEOFIL® DBM Paste (Regeneration Technologies, Inc., K043420, SE 01/10/05).

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Image /page/2/Picture/2 description: The image is a seal for the Department of Health & Human Services, USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged around the perimeter. In the center of the seal is an abstract emblem consisting of three stylized shapes that resemble a bird or a wing-like design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 2006

Medtronic Sofamor Danek % Edward S. Chin, D. Ph, MBA Group Director, Regulatory and Clinical Affairs 1800 Pyramid Place Memphis, Tennessee 38132

Re: K060794

Trade/Device Name: Progenix™M DBM Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MBP, MQV Dated: September 15, 2006 Received: September 19, 2006

Dear Dr. Chin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Edward S. Chin, D. Ph, MBA

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Aboubacar Buckner

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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December - 2006

510(k) Number (if known): K060794

PROGENIX™ DBM Putty Device Name:

Indications for Use: PROGENIX™ DBM Putty is intended for use as a bone graft substitute, and bone void filler in bony voids or gaps of the pelvis, ilium and extremities not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PROGENIX™ DBM Putty provides a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dalbare Buelur

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K060794

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.